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Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00461292
First received: April 13, 2007
Last updated: September 9, 2011
Last verified: September 2011
History of Changes
Results First Received: September 9, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Overactive Bladder
Interventions: Biological: botulinum toxin Type A (200U)
Biological: botulinum toxin Type A (300U)
Other: Normal saline (Placebo); botulinum toxin Type A (200U)
Other: Normal saline (Placebo); botulinum toxin Type A (300U)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Botulinum Toxin Type A (300U) botulinum toxin Type A (300U)
Botulinum Toxin Type A (200U) botulinum toxin Type A (200U)
Placebo Normal saline (placebo)

Participant Flow for 2 periods

 Period 1:   Treatment Cycle 1
    Botulinum Toxin Type A (300U)     Botulinum Toxin Type A (200U)     Placebo  
STARTED     91     92     92  
COMPLETED     76     80     81  
NOT COMPLETED     15     12     11  

Period 2:   Treatment Cycle 2
    Botulinum Toxin Type A (300U)     Botulinum Toxin Type A (200U)     Placebo  
STARTED     63 [1]   74 [2]   0 [3]
COMPLETED     58     72     0  
NOT COMPLETED     5     2     0  
[1] 32 from the 300U group + 31 from the Placebo group entered Cycle 2
[2] 42 from the 200U group + 32 from the Placebo group entered Cycle 2
[3] Cycle 1 Placebo pts were randomized to receive 300U or 200 U in Cycle 2



  Baseline Characteristics
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Reporting Groups
  Description
Botulinum Toxin Type A (300U) botulinum toxin Type A (300U)
Botulinum Toxin Type A (200U) botulinum toxin Type A (200U)
Placebo Normal saline (placebo)
Total Total of all reporting groups

Baseline Measures
    Botulinum Toxin Type A (300U)     Botulinum Toxin Type A (200U)     Placebo     Total  
Number of Participants  
[units: participants]
 		  91     92     92     275  
Age, Customized  
[units: participants]
 		       
< 40 years     30     31     25     86  
Between 40 and 64 years     56     55     61     172  
Between 65 and 74 years     4     5     5     14  
>= 75 years     1     1     1     3  
Gender  
[units: participants]
 		       
Female     52     54     49     155  
Male     39     38     43     120  



  Outcome Measures
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1.  Primary:   Change From Baseline in Number of Weekly Episodes of Urinary Incontinence   [ Time Frame: Baseline, Week 6 ]
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2.  Secondary:   Change From Baseline in Maximum Cystometric Capacity (MCC)   [ Time Frame: Baseline, Week 6 ]
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3.  Secondary:   Change From Baseline in Maximum Detrusor Pressure (MDP)   [ Time Frame: Baseline, Week 6 ]
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4.  Secondary:   Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire   [ Time Frame: Baseline, Week 6 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: Allergan, Inc.
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


No publications provided by Allergan

Publications automatically indexed to this study:


Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00461292     History of Changes
Other Study ID Numbers: 191622-516
Study First Received: April 13, 2007
Results First Received: September 9, 2011
Last Updated: September 9, 2011
Health Authority: United States: Food and Drug Administration